Diet Intervention for Human Microbiome Health

LW
Overseen ByLisa Whisenhunt
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Nebraska Lincoln
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different foods affect the bacteria in the gut, known as the microbiome. Participants will consume meals provided by a commercial meal service for one week. Researchers aim to identify which components of the microbiome change with these specific meals. Individuals who can read and speak English, are comfortable using an electronic food diary, and have not recently undergone cancer treatment or taken antibiotics might be suitable candidates.

As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on diet and gut health.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken antibiotics or certain medical treatments recently, you may not be eligible to participate.

What prior data suggests that this diet intervention is safe?

Research has shown that food can quickly change the bacteria in the stomach, known as the gut microbiome. One study found that even a single fast food meal can rapidly alter these bacteria. Another study discovered that increasing fiber intake for two weeks can also change the gut microbiome. These changes are usually safe, but effects can vary among individuals. In this trial, participants will eat meals provided by a commercial service for one week. These diets are generally safe for most people and help researchers understand how food impacts gut health.12345

Why are researchers excited about this trial?

Unlike traditional treatments for gut health that often involve supplements or medications, this approach uses food provided by a commercial meal service to potentially enhance the human microbiome. Researchers are excited because this method focuses on the natural impact of diet on gut bacteria, offering a more holistic and accessible way to improve microbiome health. By directly altering daily food intake, this intervention could provide insights into how specific dietary patterns influence gut health, possibly leading to personalized dietary recommendations.

What evidence suggests that this diet intervention is effective for microbiome health?

Research has shown that dietary changes can quickly impact the gut microbiome, the group of helpful bacteria in the stomach and intestines. One study found that even a single fast food meal can rapidly alter these gut bacteria. Other studies have discovered that meal plans rich in plant-based foods can improve the types of bacteria in the gut. These positive changes can enhance overall health. In this trial, participants will receive meals from a commercial service for a week, which might also offer similar benefits by positively changing the gut microbiome.13678

Who Is on the Research Team?

JI

Jacques Izard, PhD

Principal Investigator

Univeristy of Nebraska-Lincoln

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals who can consent to participate, use an electronic food diary, and eat meals provided by the study. They must have a US address. It's not for those on parenteral nutrition or with allergies to shellfish, insects, carmine, dragon fruit (pitaya), or cacti; anyone treated for cancer or given antibiotics in the last month; or those who've had certain x-rays or bowel preparations recently.

Inclusion Criteria

Only individuals able to provide a US address will be included
Willing to sign consent and have samples collected
Participants must be willing to use an electronic food diary and consume study provided foods

Exclusion Criteria

Received oral x-ray contrast within the past 1 month prior to signing consent
You are allergic to cacti.
I have taken antibiotics in the last month.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Food Intervention

Participants receive food from a commercial meal service provider to monitor microbiome changes

1 week

Follow-up

Participants are monitored for microbiome composition changes after the food intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Food provided from a commercial meal service provider for a week
Trial Overview The study tests how different foods affect the human microbiome over time. Participants will consume meals from a commercial service for one week while their microbiome changes are monitored.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Food providedExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska Lincoln

Lead Sponsor

Trials
40
Recruited
13,200+

Published Research Related to This Trial

A study involving 106 subjects over 2 years found that obese patients with severe metabolic disease (MetS-OB) had significant gut microbiome dysbiosis compared to those without metabolic dysfunction and non-obese individuals.
Both Mediterranean and low-fat diets were effective in partially restoring the gut microbiome in obese patients with severe metabolic disease, indicating that dietary interventions can positively impact gut health based on metabolic status.
Consumption of Two Healthy Dietary Patterns Restored Microbiota Dysbiosis in Obese Patients with Metabolic Dysfunction.Haro, C., García-Carpintero, S., Rangel-Zúñiga, OA., et al.[2018]

Citations

A Single Human-Relevant Fast Food Meal Rapidly ...A Single Fast Food Meal Promotes Rapid Remodeling of the Gut Microbiome. It is well known that dietary practices can have profound effects on gut microbiome ...
Diet and the Human Gut Microbiome: An International ReviewThis review summarizes the key results of recently published studies on the effects of dietary change and nutritional intervention on the human microbiome ...
Food- vs. supplement-based very-low-energy diets and gut ...The gut microbiome is intricately connected to human health and disease, and understanding the influence of diet on its composition and function ...
Short-Term Effects of Weight-Loss Meal Replacement ...We investigated the effects of weight-loss meal replacement programs with different macronutrient ratios on the gut microbiota and metabolic parameters
Effects of OsomeFood Clean Label plant-based meals on the ...Plant-based diets offer more beneficial microbes and can modulate gut microbiomes to improve human health. We evaluated the effects of the ...
Gut Microbiome Analysis for Personalized Nutrition: The ...The present review intends to summarize the state of consolidated knowledge on human gut microbiome in the context of diet and disease.
High-Fiber, Whole-Food Dietary Intervention Alters the Human ...Our results demonstrate that on a short-term timescale of 2 weeks, increased fiber intake can induce compositional changes of the gut microbiome.
Microbiome-Based Interventions for Food Safety and ...The role of microbiomes in food safety is critical, as they regulate pathogen growth and food quality. The microbiome is a complex ecosystem of microorganisms, ...
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